Annual report [Section 13 and 15(d), not S-K Item 405]

Basis of Presentation

v3.26.1
Basis of Presentation
12 Months Ended
Dec. 31, 2025
Accounting Policies [Abstract]  
Basis of Presentation

1. Basis of Presentation

 

The Company

 

Oragenics, Inc. (formerly known as Oragen, Inc.) (the “Company” or “we”) was incorporated in November 1996. Commencing in December 2023, we are focused on the development of medical products that treat brain related illnesses and diseases and our lead product candidate and focus is on the development and commercialization of ONP002 for the treatment of mild traumatic brain injury (“mTBI” or “Concussion”).

 

Basis of Presentation

 

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission applicable to annual financial reporting.

 

The consolidated financial statements include the accounts of Oragenics, Inc. and its wholly owned subsidiaries, Noachis Terra Inc. and Oragenics Australia Pty Ltd (collectively, the “Company”). All intercompany balances and transactions have been eliminated in consolidation.

 

The consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. As discussed in Note 1 Going Concern Consideration, the Company has incurred recurring losses and negative cash flows from operations, which raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

On June 3, 2025, the Company effected a 1-for-30 reverse stock split of its outstanding common stock. All share and per-share amounts in the consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse stock split for all periods presented, unless otherwise indicated.

 

Going Concern Consideration

 

In light of the Company’s recurring losses, accumulated deficit, and negative cash flows from operations, the report of the Company’s independent registered public accounting firm on the consolidated financial statements for the year ended December 31, 2025, includes an explanatory paragraph raising substantial doubt about the Company’s ability to continue as a going concern.

 

The Company has incurred losses and negative cash flows from operations since inception and has not generated significant revenues from operations. For the year ended December 31, 2025, the Company incurred a net loss of approximately $9.8 million and used approximately $9.2 million of cash in operating activities. As of December 31, 2025, the Company had an accumulated deficit of approximately $226.6 million.

 

Historically, the Company’s primary sources of liquidity have consisted of proceeds from public and private equity financings, debt financings, warrant exercises, grant income, and interest income. During the twelve months ending December 31, 2025, we raised approximately $2.6 million in net proceeds from private placements and sales of our common stock, $15 million in net proceeds from the issuance of Series H preferred stock and warrants and received approximately $2.2 million in net proceeds from the issuance of debt. We believe that this financing meaningfully extends our ability to execute on our near-term operating objectives, including continued development of ONP-002. Based on these financings, management believes that the Company’s available cash resources will be sufficient to fund planned operations through the third quarter of 2026.

 

 

The Company expects to continue to incur operating losses and negative cash flows as it advances the development of ONP-002 and supports ongoing general and administrative activities. However, based on the financing transactions completed in February, March, and July 2025, management believes the Company has sufficient liquidity to support its planned research and development activities and general corporate operations through the third quarter of 2026.

 

These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date that these consolidated financial statements are issued. The Company’s ability to continue operations beyond its current liquidity horizon is dependent upon its ability to obtain additional financing or achieve profitable operations, neither of which can be assured. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.